Government Study Finds that Some Vaccines for Kids Are Stored Improperly

Spot checks by the Office of the Inspector General found that some vaccines at 45 clinics across the country weren't stored at the correct temperature, possibly affecting their potency. But for parents concerned about having to revaccinate their kids, experts say there isn't much reason to worry.

This week, it’s likely that many pediatricians in the U.S. did some deep thinking about their office refrigerators.

On Wednesday, a government report revealed that some free vaccines for kids — those part of the nationwide Vaccines for Children (VFC) program designed to serve low-income, uninsured or underinsured children, among others — had been stored improperly. Many were kept outside the recommended temperature range of 37 to 45 degrees Fahrenheit, which could potentially decrease their potency. The VFC program accounts for up to half of all childhood immunizations, and there could be wider implications as well since many VFC providers are private clinics that also immunize insured children.

Although American parents are increasingly voicing skepticism about the necessity and safety of vaccines, the vast majority still follow their pediatricians’ advice to immunize their children against vaccine-preventable disease. This week, the American Academy of Pediatrics (AAP) rushed to reassure them that revaccination is not necessary. “If this was compromising vaccines, we would be having outbreaks everywhere,” says Atlanta pediatrician Geoffrey Simon, the incoming chair of the AAP’s practice committee.

As part of routine oversight, investigators from the Office of the Inspector General (OIG) in the Department of Health and Human Services sampled storage practices in 45 doctors’ offices in the five places that received the largest vaccine shipments in 2010 — New York City, California, Florida, Georgia and Texas. In addition to inconsistent temperatures, they also found that expired vaccines were stored alongside unexpired vaccines in some clinics, which could lead to a nurse inadvertently grabbing the wrong inoculation. “We were surprised we found what we did,” says Dwayne Grant, the regional inspector general who oversaw the report.

Manufacturers do their best to make vaccines as hardy as possible, but if they’re allowed to get too cold or too hot, they may not be as effective as properly stored vaccines. The formulations are not so delicate that they immediately become useless if too chilled or overheated; in theory, they can gradually lose potency, bit by bit. “In all likelihood, statistically it’s a non-issue,” says Paul Offit, chief of the division of infectious diseases at Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine. As a vaccine expert, Offit regularly gets calls from physicians worried that they ruined their vaccine stock by accidentally leaving the refrigerator door ajar for 20 minutes. “It’s not black or white, but I usually say I think it’s not going to be a problem.”

When inspectors visited the clinics in question, they found that most vaccines were stored appropriately most of the time. But 76% of the providers had stored vaccines at incorrect temperatures for at least five hours during the two-week period measured. Nearly a third of the clinics stored expired and unexpired vaccines together. And all the clinics had recorded temperatures that differed from the tested measurements. “We may not be taking accurate temperatures,” says Simon. “This raises the question of what is the best way to monitor temperatures and make sure vaccines stay within the recommended range. You can stick a thermometer under a kid’s arm and get a different temperature than in his ear. This illustrates this is complex stuff.”

Vaccines are big business — and a big investment. In 2010, the VFC program, which is administered by the Centers for Disease Control and Prevention (CDC), delivered 82 million vaccines to 40 million children at a cost of $3.6 billion.

At the CDC, officials said that the vaccines in question appear to be working just fine. The agency has conducted large studies of pertussis outbreaks in California and Minnesota in 2010, finding that the vaccine was more than 90% effective in the short-term. Within five years, that rate typically drops to 70%, which is why pertussis boosters are needed. Too few people getting boosters has contributed to a spike in cases in Washington state. But if improper storage had affected how well the vaccines work, public health officials would have expected mass outbreaks in all the states in the study. “We don’t think this report makes us question whether our vaccines are safe or not, but we take the results very seriously and plan to work with the states and local pediatricians’ offices to make sure they’re stored safely,” says Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory diseases at CDC.